Plum 360 Infusion System, List number 30010.
FDA Recall Z-0101-2018 · Posted None
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Recalling FirmICU Medical Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2017-10-30
Date Terminated2019-08-28
Product Quantity21,461 devices
Reason for Recall
(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.
Firm Action
The recalling firm issued letters dated 10/30/2017 via UPS on 10/30/2017 notifying their customers of the two issues.
Root Cause
Under Investigation by firm
Distribution Pattern
Distribution was nationwide to medical facilities. Foreign distribution was made to Canada and Australia. Government and military distribution was also made.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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